Observation on clinical effect of acupuncture plus Zi Shen Tiao Gan Decoction for perimenopausal insomnia

Objective: To explore the therapeutic effect of acupuncture plus Zi Shen Tiao Gan (Kidney-reinforcing and Liver-regulating) Decoction for perimenopausal women with insomnia.

Many perimenopausal women experience insomnia, an inability to fall asleep in mild cases and stay awake throughout the night in severe cases[1]. The long-term insomnia in perimenopausal women can induce psychological issues of anxiety and depression, and then aggravate the dysfunction of the endocrine and immune system and seriously influence the physical and mental health of the patients[2]. Currently, tranquilizing medications are often prescribed for insomnia. These medications do have short-term effect, however, they are potentially addictive and unlikely to eradicate insomnia[3]. By contrast, traditional Chinese medicine (TCM) is advantageous for perimenopausal insomnia. By holistic viewpoints and treatment based upon syndrome differentiation of TCM, it has been reported by some studies that insomnia can be remarkably alleviated by Chinese herbal drugs without side effects[4-6]. Therefore, the clinical observation was processed in our clinic from January of 2013 to August of 2014 in treatment of perimenopausal insomnia by acupuncture plus Zi Shen Tiao Gan (Kidney-reinforcing and Liver-regulating) Decoction. Now, the report is given as follows.

1 Clinical Data

1.1 Diagnostic criteria

The diagnostic criteria of perimenopausal period were referred to the definition in the Gynecology and Obstetrics[7]: perimenopause refers to the time periodbefore and after menopause, including from appearance of menopause-related endocrine, biological and clinical characteristics in approaching the menopause to one year after the last menstruation.

The diagnostic criteria of insomnia were referred to the definition in the seventh edition of Internal Medicine of Traditional Chinese Medicine[8]: sleep disorders at least three times per week, for over two weeks continuously; low spirit, lassitude, or dizziness and distending sensation in the head, palpitations and vexation in the daytime; not attributable to somatopathic diseases or other mental disorders; with the scores ≥12 points in the SPIEGEL scale[9].

1.2 Inclusion criteria

Those in conformity with the above diagnostic criteria; aged from 45 to 55 years old; signed the informed consent and willing to participate in the study.

1.3 Exclusion criteria

Those not in conformity with the above diagnostic criteria; with general diseases involving surgery, pain and cough that influence the sleep; with administration of sedative and hypnotic medications within one week; complicated with acute seizure of serious diseases of cardiac failure or respiratory failure; and those with mental disorders.

1.4 Statistical methods

The SPSS 17.0 version statistical software was used for statistical analysis. The comparison of the rate was processed with Chi-square test. The measurement data were processed with t-test.

1.5 General data

A total of 126 eligible cases were selected and randomly divided into an observation group and a control group by their visit order, 63 cases in each group. The patients in the two groups were tested with SPIEGEL scale (all ≥ 12 points)[9]. The score ≥ 12 points, but ＜18 points as mild insomnia; the score ≥18 points, but ＜24 points as moderate insomnia; and the score ≥ 24 points as severe insomnia. By the statistical management of the general data in the patients of the two groups, the differences were not statistically significant (all P＞0.05), indicating that the two groups were comparable (Table 1).

Table 1. Comparison of general data between the two groups

2 Therapeutic Methods

2.1 Observation group

2.1.1 Acupuncture

Acupoints: Taixi (KI 3), Sanyinjiao (SP 6), Baihui (GV 20), Sishencong (EX-HN 1), Shenmen (HT 7), Shenmai (BL 62), and Zhaohai (KI 6).

Operation: Disposable stainless steel filiform needles of 0.30 mm in diameter and 40 mm in length were selected. After the skin of acupoint areas was disinfected routinely, the needles were inserted. After the arrival of the needling sensation, the needles were manipulated with the moderate needling technique. The needles were manipulated once every 10 min while the needles were retained. The needles were withdrawn after the needles were retained for 30 min. The treatment was given once every day, for four weeks continuously.

2.1.2 Herbal drugs

Zi Shen Tiao Gan (Kidney-reinforcing and Liverregulating) Decoction was composed of Shu Di Huang (Radix Rehmanniae Praeparata) 24 g, Huang Jing (Rhizoma Polygonati) 9 g, Bai Shao (Radix Paeoniae Alba) 15 g, Gou Qi Zi (Fructus Lycii) 15 g, Tu Si Zi (Semen Cuscutae) 15 g, Shan Zhu Yu (Fructus Corni) 12 g, Bai Zi Ren (Semen Platycladi) 12 g, Fu Xiao Mai (Fructus Tritici Levis) 20 g, Xiang Fu (Rhizoma Cyperi) 12 g, Di Gu Pi (Cortex Lycii Radicis) 12 g, and Zhi Gan Cao (Radix Glycyrrhizae Praeparata) 9 g.

Administration: First herbal drugs were soaked with 500 mL warm water for 30 min, and then decocted with mild fire to boiling. After boiling for 20 min, about 200 mL of first herbal liquid was drained. Then, 300 mL of water was added and decocted for 20 min, and 150 mL of second herbal liquid was drained. Two herbal liquids were mixed and taken twice respectively in the morning and evening with empty stomach. One dose was taken every day, for four weeks continuously.

2.2 Control group

The patients in the control group were only given same acupuncture treatment as those in the observation group, with the same acupoints, therapeutic methods and course.

3 Observation on Therapeutic Effects

3.1 Criteria of therapeutic effects

Based upon the criteria of therapeutic effects on insomnia in the Revised Plan for Assessment Criteria ofTherapeutic Effects in Treatment of Mental Disorders of the Practical Psychiatrics of Traditional Chinese Medicine[10].

Cure: Sleep time was restored to normal or sleep time was over 6 h, in sound sleep, and full of energy after waking up.

Remarkable effect: Sleep was obviously improved, and sleep time was increased by over 3 h.

Effect: Sleep time was increased than before the treatment, but sleep time was increased less than 3 h.

Failure: No improvement or even aggravation after the treatment.

3.2 Results

3.2.1 Comparison of therapeutic effect between the two groups

The observation group and control group, 63 cases in each group, were processed with intervention for four weeks, without dropping-off cases.

The total effective rate was 96.8% in the observation group, remarkably higher than 74.6% in the control group. The difference in the total effective rate was statistically significant (P＜0.01), (Table 2).

3.2.2 Comparison of SPIEGEL scores before and after treatment

Before treatment, the difference in SPIEGEL score between the two groups was not statistically significant (P ＞ 0.05). After treatment, the SPIEGEL score was obviously lower in the observation group than that in the control group (P＜0.05). In the comparison of the difference values of SPIEGEL scores before and after treatment between the two groups, the results showed that the difference was statistically significant (P＜0.05). The difference in SPIEGEL score between before and after treatment in the control group were statistically significant (P＜0.05). The difference in SPIEGEL score between before and after treatment in the observation group was more remarkably significant (P ＜ 0.01), (Table 3).

Table 2. Comparison of therapeutic effect between the two groups (case)

Table 3. Comparison of SPIEGEL score before and after treatment between the two groups (x ±s, point)

4 Discussion

It has been proven that acupuncture can improve sleep to a certain extent in patients with insomnia[4]. It is believed in TCM that insomnia in the perimenopausal period belongs to the scope of poor sleep and various syndromes before and after menopause. The principles of treatment are to nourish yin, subdue fire, clean the heart, calm the mind, and regulate yin and yang, so as to balance yin and yang and eliminate various symptoms. In accordance with this therapeutic principle, Taixi (KI 3), Sanyinjiao (SP 6), Baihui (GV 20), Sishencong (EX-HN 1), Shenmen (HT 7), Shenmai (BL 62), and Zhaohai (KI 6) were selected in this study. Taixi (KI 3), the Yuan-Primary acupoint from the Kidney Meridian of Foot Shaoyin, has the effects to reinforce the kidney, benefit yin and dredge the meridians. Sanyinjiao (SP 6) is a crossing acupoint of the Liver Meridian, Spleen Meridian and Kidney Meridian, and has the effects to reinforce essence, blood, benefit the liver and kidney and soothe the liver qi. Baihui (GV 20) is an acupoint from the Governor Vessel and has the effects to clean the head and eyes and calm the mind. Sishencong (EX-HN 1) is an extraordinary acupoint and is able to assist Baihui (GV 20) to guide yang into yin and restore the balance between yin and yang. Shenmen (HT 7) is the Yuan-Primary acupoint of the Heart Meridian of Hand Shaoyin and is able to tranquilize the heart and calm down the mind. Zhaohai (KI 6) is an acupoint of Foot Shaoyin Meridian and has the effects to nourish yin and reinforce the kidney. All the acupoints in combination can deal with the symptoms and the root causative factors and calm the mind.

In this study, Zi Shen Tiao Gan (Kidney-reinforcing and Liver-regulating) Decoction is composed of Shu Di Huang (Radix Rehmanniae Praeparata), Huang Jing (Rhizoma Polygonati), Bai Shao (Radix Paeoniae Alba), Gou Qi Zi (Fructus Lycii), Tu Si Zi (Semen Cuscutae), Shan Zhu Yu (Fructus Corni), Bai Zi Ren (Semen Platycladi), Fu Xiao Mai (Fructus Tritici Levis), Xiang Fu (RhizomaCyperi), Di Gu Pi (Cortex Lycii Radicis), and Zhi Gan Cao (Radix Glycyrrhizae Praeparata). In this herbal formula, Shu Di Huang (Radix Rehmanniae Praeparata) and Bai Shao (Radix Paeoniae Alba) are monarch drugs. Shan Zhu Yu (Fructus Corni), Gou Qi Zi (Fructus Lycii) and Tu Si Zi (Semen Cuscutae) are minister drugs. Fu Xiao Mai (Fructus Tritici Levis), Bai Zi Ren (Semen Platycladi), Di Gu Pi (Cortex Lycii Radicis), Xiang Fu (Rhizoma Cyperi) and Huang Jing (Rhizoma Polygonati) are adjuvant drugs. Zhi Gan Cao (Radix Glycyrrhizae Praeparata) is a messenger drug. Shu Di Huang (Radix Rehmanniae Praeparata) in sweet flavor, in tropism to the Liver Meridian and the Kidney Meridian, is able to tonify blood, nourish yin, tonify essence and marrow, and is an important drug to reinforce the kidney yin. Bai Shao (Radix Paeoniae Alba), in tropism to the Liver Meridian and the Spleen Meridian, is able to nourish blood and settle yin, nourish liver to stop pain, and is an important drug to reinforce and benefit the liver blood. Shan Zhu Yu (Fructus Corni) is supposed to tonify the liver and kidney, promote astringent and containing actions, and is an important drug to nourish yin and yang moderately. Gou Qi Zi (Fructus Lycii) can be used to treat insufficiency of the liver and kidney and deficiency of essence and blood. Tu Si Zi (Semen Cuscutae) is able to nourish the liver, improve eyesight, stop diarrhea and replenish yin and yang moderately. The combination of above drugs plays a better role in balancing yin and yang, so as to greatly improve the sleeping quality of the patients.

The accurate efficacy of acupuncture combined with Zi Shen Tiao Gan (Kidney-reinforcing and Liverregulating) Decoction for insomnia may be related to that this therapeutic method is able to improve the endocrine functions and nervous system of women during the perimenopausal period[11-13]. The earliest change in the perimenopausal period is hypoovarianism, leading to gradual increase to the resistance of gonadotropin stimulation. It has been proven that herbal drugs with the functions of estrogens mostly contain plant estrogens[11], such as Ren Shen (Radix Ginseng), Tu Si Zi (Semen Cuscutae), Gou Qi Zi (Fructus Lycii), etc. These herbal drugs can promote secretion of estrogens and intensify the expression of estrogen receptor. It has been proven that acupuncture can regulate the endocrine system of the body to a certain extent, having a better regulatory effect for hypothalamus-pituitary-ovarian axis for elevating the ovarian functions and postponing the decline of the ovarian functions[12]. The women in the perimenopausal period are mainly troubled by symptoms of autonomic dysfunction[13]. The treatment by herbal medicine and acupuncture can influence the neurotransmitters of monoamine transmitter and β-endophin, so as to regulate the nervous functions of the patients, and improve the patient’s sleep[11-13].

It is shown by the results of this study that the total effective rate is 96.8% in the observation group, remarkably higher than 74.6% in the control group, with the statistical significance in the differences between the two groups. The results indicate that acupuncture plus Zi Shen Tiao Gan (Kidney-reinforcing and Liverregulating) Decoction for perimenopausal insomnia is precise in the therapeutic effect, and the therapeutic effect is better than simple acupuncture treatment, so as to indicate that acupuncture in combination of Zi Shen Tiao Gan (Kidney-reinforcing and Liver-regulating) Decoction can regulate the endocrine functions and nervous functions for the patients with perimenopausal insomnia, and can avoid side effects from sedatives. Therefore, it is a simple and effective clinical intervention for the patients with perimenopausal insomnia, and needs to be studied profoundly.

Conflict of Interest

The authors declared that there was no potential conflict of interest.

Acknowledgments

This work was supported by Tongde Hospital of Zhejiang Province.

Statement of Informed Consent

All of the patients in the study signed the informed consent.

Received: 30 August 2014/Accepted: 28 September 2014

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Translator: Huang Guo-qi (黃國琪)

針刺配合滋腎調(diào)肝湯治療圍絕經(jīng)期失眠癥的療效觀察

Tan Ke-ping (譚克平), Yao Xu (姚旭), Li Xin-wei (李新偉)
Department of Acupuncture and Moxibustion, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China

目的：探討針刺配合滋腎調(diào)肝湯治療圍絕經(jīng)期婦女失眠癥的療效。方法：將符合納入標(biāo)準(zhǔn)的 126 例患者隨機分成兩組，每組63例，觀察組采用針刺配合滋腎調(diào)肝湯治療，對照組采用與觀察組相同的針刺治療，連續(xù)干預(yù) 4 星期后評價療效。結(jié)果：觀察組總有效率為 96.8%，對照組為 74.6%，兩組總體療效比較有統(tǒng)計學(xué)意義(P＜0.01)。治療后，兩組 SPIEGEL 量表評分均與本組治療前有統(tǒng)計學(xué)差異(P＜0.05，P＜0.01)；兩組治療前后 SPIEGEL量表評分差值有統(tǒng)計學(xué)差異(P＜0.05)。結(jié)論：針刺配合滋腎調(diào)肝湯治療女性圍絕經(jīng)期失眠癥效果確切，且療效優(yōu)于單純的針刺治療。

針刺療法; 針?biāo)幉⒂? 中草藥; 圍絕經(jīng)期; 失眠癥

R246.6

A

Author: Tan Ke-ping, master of medicine, attending physician of traditional Chinese medicine.

E-mail: zzhflc@163.com

Tan KP, Yao X, Li XW. Observation on clinical effect of acupuncture plus Zi Shen Tiao Gan Decoction for perimenopausal insomnia.J Acupunct Tuina Sci, 2015, 13 (1): 49-53

10.1007/s11726-015-0822-1

Methods: A total of 126 eligible cases were randomly divided into two groups, 63 cases in each group. Patients in the observation group were given acupuncture plus Zi Shen Tiao Gan (Kidney-reinforcing and Liver-regulating) Decoction. Those in the control group were treated with the same acupuncture treatment as the observation group. The therapeutic effects were assessed after continuous treatment for four weeks.

Results: The total effective rate was 96.8% in the observation group and 74.6% in the control group. The comparison of the total clinical effects between the two groups was statistically significant (P＜0.01). After treatment, the intra-group comparisons of SPIEGEL score were statistically significant in both groups (P＜0.05, P＜0.01); the inter-group comparison of SPIEGEL score difference between before and after treatment was statistically significant (P＜0.05).

Conclusion: Acupuncture plus Zi Shen Tiao Gan (Kidney-reinforcing and Liver-regulating) Decoction for perimenopausal insomnia is affirmative in the therapeutic effect, and the therapeutic effect is better than simple acupuncture treatment. Keywords: Acupuncture Therapy; Acupuncture Medication Combined; Drugs, Chinese Herbal; Perimenopause; Insomnia